OPTIMIZER Smart System

FDA premarket approval P180036 · Implantable pulse generator

PMA numberP180036

Approval

Applicant
Impulse Dynamics (Usa), Inc.
Received
September 5, 2018
Decision date
March 21, 2019 (APPR)
Supplements
41, latest May 13, 2026
Product code
QFV – Implantable Pulse Generator

Official FDA PMA record

Approval order statement

Approval for the OPTIMIZER Smart System. The device which delivers Cardiac Contractility Modulation therapy, is indicated to improve 6-minute hall walk distance, quality of life, and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline directed medical therapy, who are in normal sinus rhythm, are not indicated for Cardiac Resynchronization Therapy, and have a left ventricular ejection fraction ranging from 25% to 45%.